Manager, Clinical Data Innovation
About The Position
The Manager, Clinical Data Innovation, within the GCDO Business & Technology Capabilities department, implements clinical studies on Jazz’s centralized clinical data platform and supports adoption of the platform by study teams. The role helps teams use data and technology for oversight, medical monitoring, clinical data review, and risk-based quality management. The position serves as a subject matter expert on the platform, implements new studies, and advises clinical trial working groups on the use of interactive data listings and analytics to improve trial start-up and conduct. It also participates in departmental and cross-functional initiatives to assess and implement technologies that transform clinical trial execution. The role leads implementation of processes and technologies for reviewing and trending clinical trial data, and oversees end-to-end study implementation on the platform, including vendor RFP review, data imports, user acceptance testing, and delivery of standard and custom listings and visualizations. It works with cross-functional teams, external vendors, and data managers to support platform use and automate acquisition of clinical data. Additional work may include programming QlikSense visualizations, configuring centralized monitoring methods, and supporting platform development and software updates in accordance with user requirements and GxP requirements.
Requirements
- In-depth knowledge of clinical trial planning, start-up, and conduct concepts and challenges that can be addressed using data visualizations.
- Excellent verbal and written communication skills, including explaining technical concepts to non-technical audiences and communicating business requirements to technical programmers.
- Strong problem-solving skills focused on clinical data and on technical and data problems.
- Experience eliciting and documenting requirements for dashboards, reports, or data review listings using agile methodologies or principles.
- Ability to prioritize and handle multiple tasks simultaneously in a cross-functional team environment.
- In-depth understanding of regulatory, industry (GCP), and technology standards and requirements, including ICH E6, regulatory guidelines, and SDLC.
- Bachelor’s or master’s degree in Biology, Mathematics, Computer Science, or a related field.
- 3–5+ years of relevant work experience, such as clinical trial execution and/or clinical systems implementation.
Nice To Haves
- Experience with the elluminate platform.
- Experience applying advanced analytics, including machine learning methods, to clinical trials.
- Experience with T-SQL, QlikSense, R, or Python.
- Knowledge of ICH E6 (R2) Risk Based Quality Management.
- Experience supporting or performing centralized statistical monitoring.
Responsibilities
- Lead implementation of processes and technologies used to review and trend clinical trial data during study conduct.
- Lead end-to-end implementation of clinical studies on the clinical data platform, including vendor RFP review, data imports, user acceptance testing, and delivery of standard and custom listings and visualizations.
- Build relationships with cross-functional clinical trial working groups and advise them on using the platform to meet objectives in functional plans, such as data review, medical monitoring, and risk management plans.
- Contribute to developing software systems and infrastructure for efficient, user-friendly clinical study data displays and metrics reports.
- Collaborate with external vendors and data managers to automate acquisition of clinical data into the platform.
- Promote best practices for application use and identify and implement solutions that support comprehensive adoption and effective use of the platform.
- Identify and implement continuous improvement initiatives for Clinical Data Innovation team processes.
- May program QlikSense visualizations showing clinical trial start-up and conduct.
- May configure and program centralized data monitoring methods to support risk-based quality management.
- May support ongoing development of the clinical data platform, including software updates, and ensure deliverables meet system user requirements and GxP requirements.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement savings plan
- Flexible paid vacation
- May be eligible for a discretionary annual cash bonus or incentive compensation, depending on the role.
- May be eligible for discretionary equity grants.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
